# FDA 483 - B&W TEK, Inc. - December 08, 2021

Source: https://www.globalkeysolutions.net/records/483/bw-tek-inc/a542dc8a-cb40-4554-b16b-e2de5350015c

> FDA 483 for B&W TEK, Inc. on December 08, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: B&W TEK, Inc.
- Inspection Date: 2021-12-08
- Product Type: device
- Office Name: Philadelphia District Office
- Summary: B&W TEK, Inc., a medical device manufacturer in Newark, DE, was cited for two observations during an FDA inspection. The firm failed to validate a manufacturing process according to established procedures, specifically lacking completion of a Performance Qualification study. Additionally, products not conforming to specifications were not adequately controlled, as an out-of-specification result was not evaluated for necessary investigation.

## Related Officers

- [Investigations](https://www.globalkeysolutions.net/people/edward-d-mcdonald/69224613-2b96-426a-99dd-e1cfe5ff1713)

Company: https://www.globalkeysolutions.net/companies/bw-tek-inc/eff89bfd-776f-44da-88cd-04cfa3809084

Office: https://www.globalkeysolutions.net/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8